COVID-19 and investments will shape the outsourcing industry for the near term.

CMOs and CDMOs: Pandemic and Beyond

Advances in technology are accelerating the development and manufacture of subunit vaccines.

Subunit Vaccines and the Fight Against COVID-19

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Articles

Biden outlines a plan to end the pandemic in a virtual global conference.

Biden Hosts Global COVID-19 Summit

The FDA has amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to allow a single booster dose to several high-risk populations.

FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

New data finds J&J COVID-19 vaccine and booster to provide increased protection against COVID-19. 

Real-World Evidence Shows Strong Protection from COVID-19 with J&J Vaccine and Booster

The topline data from Pfizer and BioNTech’s trial suggests that a 10 µg vaccine is safe and effective among the 5 to 11 age group.

 Pfizer and BioNTech Announce Positive Results In COVID-19 Vaccine Trial for Children Ages 5 to 11

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Pfizer-BioNTech announced plans to seek FDA approval this month of a smaller dose of its Comirnaty vaccine for children ages 5–11.

Next Big COVID Challenge: Vaccines for Little Kids

FDA advisors agreed unanimously on a more limited booster plan after rejecting Pfizer’s original request to authorize its third shot for everyone over age 16.

Vaccine Booster Battle Reveals Rifts Among Regulators and Sponsors

Health Canada approved the new drug submission for Spikevax—more commonly known as the Moderna COVID-19 vaccine—for active immunization to prevent COVID-19 in individuals 12 years of age and older.

Health Canada Approves Moderna’s COVID-19 Vaccine, Spikevax, for 12 Years & Up

FDA revised the emergency use authorization for bamlanivimab and etesevimab (administered together) to include emergency use as post-exposure prophylaxis (prevention) for COVID-19.

FDA Revises EUA for Use of Bamlanivimab and Etesevimab for Post-Exposure Prophylaxis Prevention for COVID-19

Moderna’s newest insights include an overall efficacy review, a study on breakthrough infections, and a study on long-term immunity.

Moderna Releases New Clinical Data on COVID-19 Vaccine

Exscientia has entered into a four-year agreement with the Bill & Melinda Gates Foundation for the development of small-molecule therapeutics that can tackle coronavirus and other viruses with pandemic potential.

COVID-19 Update

CMOs and CDMOs: Pandemic and Beyond

Subunit Vaccines and the Fight Against COVID-19